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A Phase I/II Study of the Safety and Efficacy of Topical 1-(S)-(3-Hydroxy-2-Phosphonylmethoxypropyl)Cytosine Dihydrate (Cidofovir; HPMPC) in the Treatment of Refractory Mucocutaneous Herpes Simplex Disease in Patients With AIDS

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002116
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: December 1995
  Purpose

To evaluate the safety and tolerance of topical cidofovir (HPMPC) therapy for refractory mucocutaneous herpes simplex virus disease in AIDS patients. To determine whether topical HPMPC therapy can induce re-epithelialization and healing of refractory mucocutaneous herpes simplex virus disease in AIDS patients. To evaluate the virologic effects of topical HPMPC therapy on herpes simplex virus shedding from refractory lesions.


Condition Intervention Phase
Herpes Simplex
HIV Infections
Drug: Cidofovir
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase I/II Study of the Safety and Efficacy of Topical 1-(S)-(3-Hydroxy-2-Phosphonylmethoxypropyl)Cytosine Dihydrate (Cidofovir; HPMPC) in the Treatment of Refractory Mucocutaneous Herpes Simplex Disease in Patients With AIDS

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 30
Detailed Description:

Patients are randomized to receive topical therapy with placebo (vehicle alone) or HPMPC at either 0.3 or 1.0 percent once daily for 5 days. Patients are assessed to day 15; those with no significant toxicity are eligible to receive open-label topical HPMPC for up to 6 months.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Antiretroviral therapy with AZT, ddI, ddC, or d4T.
  • Oral trimethoprim/sulfamethoxazole.
  • Dapsone.
  • Atovaquone.
  • Fluconazole.
  • Rifabutin.
  • Clarithromycin.

Patients must have:

  • HIV seropositivity.
  • Mucocutaneous herpes simplex virus (HSV) infection confirmed by previous viral culture and persisting without improvement despite at least 10 days of acyclovir at a minimum dose of 1 g/day (oral) or 15 mg/kg/day (intravenous).
  • Measurable lesions.
  • Consent of parent or guardian if less than 18 years of age.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

Active medical problems sufficient to hinder study compliance or assessment of treatment effect.

Concurrent Medication:

Excluded:

  • Acyclovir.
  • Immunomodulators (such as corticosteroids or interferons).
  • Lymphocyte replacement therapy.
  • Biologic response modifiers.
  • Ganciclovir.
  • Foscarnet.
  • Vidarabine.
  • Topical trifluridine.
  • Other investigational drugs (except d4T).
  • Amphotericin.
  • Intravenous therapy for PCP.
  • Chemotherapeutic agents.

Prior Medication:

Excluded within 14 days prior to study entry:

  • Immunomodulators (such as corticosteroids or interferons).
  • Lymphocyte replacement therapy.
  • Biologic response modifiers.
  • Ganciclovir.
  • Foscarnet.
  • Vidarabine.
  • Topical trifluridine.
  • Other investigational drugs with potential anti-HSV activity.
  • Amphotericin.
  • Intravenous therapy for PCP.

Excluded within 4 weeks prior to study entry:

  • Chemotherapeutic agents.

Required:

  • At least 10 days of prior acyclovir at a minimum dose of 1 g/day (oral) or 15 mg/kg/day (intravenous).

Substance abuse.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002116

Locations
United States, California
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
Mount Zion Med Ctr / UCSF
San Francisco, California, United States, 94115
UCSF - San Francisco Gen Hosp
San Francisco, California, United States, 94110
United States, Illinois
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
United States, Maryland
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21205
United States, North Carolina
Univ of North Carolina Hosps
Chapel Hill, North Carolina, United States, 27599
United States, Texas
Park Plaza Hosp
Houston, Texas, United States, 77004
United States, Washington
Univ of Washington / Viral Disease Clinic
Seattle, Washington, United States, 98122
Canada, British Columbia
Univ of British Columbia / Univ Hosp
Vancouver, British Columbia, Canada
Sponsors and Collaborators
Gilead Sciences
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00002116     History of Changes
Other Study ID Numbers: 218A, GS-93-301
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Herpes Simplex
Acquired Immunodeficiency Syndrome
Antiviral Agents
cidofovir

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Herpes Simplex
DNA Virus Infections
Herpesviridae Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Skin Diseases
Skin Diseases, Infectious
Skin Diseases, Viral
Slow Virus Diseases
Virus Diseases
Cidofovir
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014